Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

EC Number:

256-050-0

EC Name:

Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

Cas Number:

43035-18-3

Molecular formula:

C32H26N4O7S.1/2Ca

IUPAC Name:

calcium bis(4-{[3-({2-hydroxy-3-[(4-methoxyphenyl)carbamoyl]-1-naphthyl}diazenyl)-4-methylbenzoyl]amino}benzenesulfonate)

Test material form:

solid: nanoform, no surface treatment

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WISKf(SPF71), Hoechst AG, breeding colony
- Weight at study initiation: 172 g +/- 3.39 g
- Fasting period before study: 16 h
- Housing: grouped, plastic cages
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

demineralised

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 %

Doses:

10000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

- no deaths occurred

Clinical signs:

other: - no animal showed any clinical symptoms - faeces was red-coloured

Gross pathology:

- animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Single application of 10000 mg test substance per kg bw did not cause lethality in female Wistar-rats during the 14 day observation period, resulting in a LD50 > 10000 mg/kg bw.

Executive summary:

Female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 10000 mg/kg bw (25% in demineralized water). No animal died during the 14 day observation period, resulting in a LD50 >10000 mg/kg bw.